Pleural Effusion, Pleural Effusion, Malignant, Pleural Pleurisy Effusion
Conditions
Keywords
Personalized video training, Thoracocentesis, Pleural tap
Brief summary
Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.
Detailed description
100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.
Interventions
OTHERPersonalized training video
Using a few demographic and medical details of the patients, provided by the medical staff, the video generator will create a 2-minute personalized custom video, suitable to the age, gender, language, and medical condition of the patients. No identifying information will be used, to protect patient's privacy.
Sponsors
GistMed Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers * Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap * Patients who can read and understand the questions * Patients who were interested in participating in the clinical trial and signed an informed consent form
Exclusion criteria
* Minors \< 18 years of age * Pregnant women * Patients who cannot read and understand, at the discretion of the investigator * Patients which their medical condition does not allow them to undergo the study procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fulfillment of need for information gap | 30 minutes | Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm |
| Assessment of Anxiety | 30 minutes | Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The need of an active role | 30 Minutes | The patients will be asked to score whether the explanation allowed them the active role they needed, based on the Picker Patient Experience (PPE-15) Questionnaire. The score in the intervention arm will be compared to the one of the control arm |
| Confidence and Knowledge to take actions | 30 minutes | The patient would be asked to score whether the information they received allowed them to understand what they should do next, based on the Patient Activation Measure (PAM) Questionnaire. The score in the intervention arm will be compared to the one of the control arm |
Countries
Israel
Contacts
Primary ContactOrit Neudorfer, MD
Backup ContactOri Rogovsky, MD
Outcome results
None listed